Back to resultsEvaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers
Primary Purpose
Leg Ulcer, Varicose Ulcer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Celaderm (Frozen Cultured Epidermal Allograft)
Celaderm (Frozen Cultured Epidermal Allograft)
Control (compression bandaging)
Sponsored by
About this trial
This is an interventional treatment trial for Leg Ulcer focused on measuring wound, leg, venous, chronic, wound healing
Eligibility Criteria
Inclusion Criteria:
- venous ulcer > 1 month and < 12 months in duration; 2 to 20 sq cm in surface area; not infected
- confirmatory venous ultrasound showing prior DVT and concurrent venous reflux
- ankle-brachial index 0.80 or greater
Exclusion Criteria:
- cutaneous malignancy
- recent treatment with corticosteroids or chemotherapeutic agents
- wound exposed bone, tendon or neurovascular structure
- wound infected and requiring antibiotics
Sites / Locations
- Dr. Robert Snyder
- National Center for Limb Preservation
- Beth Israel Deaconess Medical Center, Division of Podiatry
- Center for Curative & Palliative Wound Care, Calvary Hospital
- State University of New York Stony Brook
- University of North Carolina at Chapel Hill, Division of Vascular Surgery
- Blair Medical Associates, Inc., Station Medical Center, Associates Wound Clinic
- Peripheral Vascular Associates, P.A.
- Dixie Regional Medical Center, Wound Care
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control
Celaderm, Bi-Weekly
Celaderm, Weekly
Arm Description
Multi-layer compression bandaging (Profore)
Celaderm, bi-weekly applications, up to a maximum of four applications
Celaderm, applied weekly, up to a maximum of four applications
Outcomes
Primary Outcome Measures
Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation.
The primary efficacy observation was the proportion of wounds that achieved complete wound closure after 12 weeks of active treatment (i.e. of of Week 15 including screening/wash-in phase.)
Secondary Outcome Measures
Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment.
Re-epithelialization was judged by the Medical Monitor based upon computerized planimetry of serial wound photographs.
Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period.
The proportion of patients who had a recurrence of the study ulcer during follow-up after achieving wound closure during the active treatment period.
Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks).
The proportion of patients achieving wound closure by the end of the study follow-up period, 90 days after the end of the active treatment period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00399308
Brief Title
Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers
Official Title
An Initial Evaluation Of The Safety And Activity Of Celaderm(TM) Treatment Regimens In Healing Venous Leg Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2007 (Actual)
Primary Completion Date
April 30, 2008 (Actual)
Study Completion Date
April 30, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg ulcers and to give preliminary information about the efficacy of two different Celaderm(TM) dosing regimens.
Detailed Description
Celaderm(TM) weekly for four weeks or biweekly for four treatments combined with Profore(R) compression vs. Profore(R) compression alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Ulcer, Varicose Ulcer
Keywords
wound, leg, venous, chronic, wound healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Multi-layer compression bandaging (Profore)
Arm Title
Celaderm, Bi-Weekly
Arm Type
Experimental
Arm Description
Celaderm, bi-weekly applications, up to a maximum of four applications
Arm Title
Celaderm, Weekly
Arm Type
Experimental
Arm Description
Celaderm, applied weekly, up to a maximum of four applications
Intervention Type
Device
Intervention Name(s)
Celaderm (Frozen Cultured Epidermal Allograft)
Other Intervention Name(s)
Frozen Cultured Epidermal Allograft (CEA), Cultured Keratinocytes
Intervention Description
Four biweekly applications of Celaderm plus compression therapy
Intervention Type
Device
Intervention Name(s)
Celaderm (Frozen Cultured Epidermal Allograft)
Other Intervention Name(s)
Frozen Cultured Epidermal Allograft (CEA), Cultured Keratinocytes
Intervention Description
Four weekly applications of Celaderm plus compression therapy
Intervention Type
Device
Intervention Name(s)
Control (compression bandaging)
Other Intervention Name(s)
Profore
Intervention Description
Multi-layer compression bandaging
Primary Outcome Measure Information:
Title
Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation.
Description
The primary efficacy observation was the proportion of wounds that achieved complete wound closure after 12 weeks of active treatment (i.e. of of Week 15 including screening/wash-in phase.)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment.
Description
Re-epithelialization was judged by the Medical Monitor based upon computerized planimetry of serial wound photographs.
Time Frame
12 Weeks
Title
Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period.
Description
The proportion of patients who had a recurrence of the study ulcer during follow-up after achieving wound closure during the active treatment period.
Time Frame
Variable - minimum of 12 weeks of follow-up.
Title
Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks).
Description
The proportion of patients achieving wound closure by the end of the study follow-up period, 90 days after the end of the active treatment period.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
venous ulcer > 1 month and < 12 months in duration; 2 to 20 sq cm in surface area; not infected
confirmatory venous ultrasound showing prior DVT and concurrent venous reflux
ankle-brachial index 0.80 or greater
Exclusion Criteria:
cutaneous malignancy
recent treatment with corticosteroids or chemotherapeutic agents
wound exposed bone, tendon or neurovascular structure
wound infected and requiring antibiotics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Robert Snyder
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
National Center for Limb Preservation
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Beth Israel Deaconess Medical Center, Division of Podiatry
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Center for Curative & Palliative Wound Care, Calvary Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
State University of New York Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
University of North Carolina at Chapel Hill, Division of Vascular Surgery
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Blair Medical Associates, Inc., Station Medical Center, Associates Wound Clinic
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Peripheral Vascular Associates, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Dixie Regional Medical Center, Wound Care
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
12. IPD Sharing Statement
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Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers
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